Indicators for surgical staplers

ABSTRACT

A surgical stapler including one or more visual indicators is provided. The surgical stapler includes a body and a stapling assembly positioned at a distal portion of the body. The stapling assembly includes a cartridge assembly and an anvil assembly. An alignment pin is mounted on the stapling assembly and configured to engage the anvil assembly. A visual indicator of engagement of the alignment pin with the anvil assembly, clamping and/or stapling can be provided.

This application claims priority from provisional application Ser. No.61/291,486, filed Dec. 31, 2009, the entire contents of which areincorporated herein by reference.

BACKGROUND

1. Technical Field

The present disclosure relates generally to a surgical staplingapparatus and, more specifically, to a surgical stapling apparatushaving a mechanism for indicating to the user the condition of thestapler.

2. Background of Related Art

Surgical stapling instruments used for applying parallel rows of staplesthrough compressed living tissue are well known in the art, and arecommonly used, for example, for closure of tissue or organs prior totrans-section, prior to resection, or in anastomoses, and for occlusionof organs in thoracic and abdominal procedures.

Typically, such surgical stapling instruments include an anvil assembly,a cartridge assembly for supporting an array of surgical staples, anapproximation mechanism for approximating the anvil and cartridgeassemblies, an alignment pin assembly for capturing tissue between thecartridge and anvil assemblies and for maintaining alignment between thecartridge and anvil assemblies during approximation and firing, and afiring mechanism for ejecting the surgical staples from the cartridgeassembly. The approximation mechanism and the firing mechanism generallyinclude distinct actuators for effecting approximation and firing of thestaples.

A continuing need exists for a surgical stapler which provides a userwith visual indication of the stage of actuation of the surgicalstapler.

SUMMARY

A surgical stapler including one or more visual indicators is provided.In one aspect, the surgical stapler includes a body and a staplingassembly positioned at a distal portion of the body including acartridge assembly and an anvil assembly. An alignment pin is mounted onthe stapling assembly and includes an alignment pin configured to engagethe anvil assembly. A pin receiving mechanism is positioned on the anvilassembly and configured to illuminate a visual indicator upon engagementof the alignment pin with the anvil assembly.

The pin receiving mechanism may include an alignment cap mounted on anend of the anvil assembly and including an opening therein for receivingthe alignment pin and a switch assembly mounted within the alignment capconfigured to effect illumination of the visual indicator upon receptionof the alignment pin with the opening the alignment cap. The pinalignment visual indicator may include an LED mounted on the body.

The stapler may further include a clamp slide member slidably disposedwithin the body, the cartridge assembly supported adjacent a distalportion of the clamp slide member, and the clamp slide member beingmovable from a retracted position to an advanced position to approximatethe cartridge assembly towards the anvil assembly. The clampingindicator mechanism can be configured to illuminate a visual indicatorupon approximation of the cartridge assembly and/or upon completeadvancement of the clamp slide member. The clamping indicator mechanismcan be operably mounted between the body and the clamp slide member. Theclamping indicator mechanism may include an actuator mounted to theclamp slide member and a switch assembly mounted to the body andconfigured to be engaged by the actuator. The actuator may be configuredto engage the switch assembly upon complete distal advancement of the atleast one clamp slide member. The clamping visual indicator may includean LED mounted on the body.

The stapler may also include a thrust bar slidably disposed within thebody and operably connected to the cartridge assembly to cause therelease of staples therefrom upon complete distal advancement of thethrust bar. The stapling indicator mechanism can be configured toilluminate a visual indicator upon release of the staples from thecartridge assembly. The stapling indicator mechanism can be operablymounted between the body and the thrust bar. The stapling indicatormechanism may include an actuator mounted to the thrust bar and a switchassembly mounted to the body and configured to be engaged by theactuator. The actuator may be configured to engage the switch assemblyupon complete distal advancement of the thrust bar. The stapling visualindicator may include an LED mounted on the body.

In another aspect, the present disclosure provides a surgical staplercomprising a body, a stapling assembly operably mounted on a distalportion of the body, the stapling assembly including a cartridgeassembly and an anvil assembly. A clamp slide member is slidablydisposed within the body, the cartridge assembly supported adjacent adistal portion of the clamp slide member, and the clamp slide memberbeing movable from a retracted position to an advanced positioned toapproximate the cartridge assembly towards the anvil assembly. Aclamping indicator mechanism is operably mounted between the body andthe clamp slide members. The clamping indicator mechanism is configuredto illuminate a visual indicator upon complete advancement of the clampslide member.

In some embodiments, the clamping indicator mechanism includes anactuator mounted to the clamp slide member and a switch assembly mountedto the body and configured to be engaged by the actuator. The visualindicator of the clamping indicator mechanism may include an LED mountedon the body. In some embodiments, a thrust bar is slidably disposedwithin the body and operably connected to the cartridge assembly tocause the release of staples therefrom upon complete distal advancementof the thrust bar. A stapling indicator mechanism can be operablymounted between the body and the thrust bar and configured to illuminatea visual indicator upon release of the staples from the cartridgeassembly.

In another aspect, the stapler includes a body, a stapling assembly, anda thrust bar slidably disposed within the body and operably connected tothe cartridge assembly to cause the release of staples therefrom uponcomplete distal advancement of the thrust bar. A stapling indicatormechanism is operably mounted between the body and the thrust bar andconfigured to illuminate a visual indicator upon release of staples fromthe cartridge assembly.

The stapling visual indicator can include an LED mounted on the body.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the presently disclosed surgical stapling apparatus aredescribed herein with reference to the drawings, wherein:

FIG. 1 is a side view of an embodiment of a surgical stapler inaccordance with the present disclosure;

FIG. 2 is a partial side view of the internal structure of the surgicalstapler of FIG. 1;

FIG. 3 is a side view of the stapling assembly of the surgical staplerof FIG. 1;

FIG. 4 is an enlarged perspective view of a release button of thesurgical stapler of FIG. 1;

FIG. 5 is a side view of the stapling assembly of FIG. 3, with analignment pin in an advanced position;

FIG. 6 is a perspective view of an end cap of the surgical stapler ofFIG. 1;

FIG. 7 is a side view of the surgical stapler of FIG. 1, with a pinalignment LED indicator illuminated to indicate the alignment pin is inan advanced position;

FIG. 8 is a side view of the surgical stapler of FIG. 1 in a clampedcondition;

FIG. 9 is an end view of the surgical stapler of FIG. 8, with a clampingLED indicator illuminated to indicate the stapler is in a clampedcondition;

FIG. 10 is a side view of the surgical stapler of FIG. 1 in a firedcondition; and

FIG. 11 is an end view of the surgical stapler of FIG. 10, with astapling LED indicator illuminated to indicate the stapler is in a firedcondition.

DETAILED DESCRIPTION

An embodiment of the presently disclosed surgical stapling device willnow be described in detail with reference to the drawings, wherein likereference numerals designate corresponding elements in each of theseveral views. Throughout this description, the term “proximal” willrefer to the portion of the instrument closer to the operator and theterm “distal” will refer to the portion of the instrument further fromthe operator. The device described herein fires surgical staples whichare advanced into anvil pockets and deformed. It is also contemplatedthat the device utilizes two part fasteners wherein the fasteners engageretainers in the anvil section of the device.

With reference to FIG. 1, a surgical stapling device according to anembodiment of the present disclosure is shown generally as surgicalstapler 10. Surgical stapler 10 includes a body 12 defining a stationaryhandle 14, a pivotable trigger 16, an elongated central body portion 18,a cartridge assembly 20 and an anvil assembly 22. A thumb button 24 isslidably positioned on each side of body 12. Thumb buttons 24 aremovable distally to manually advance an alignment pin 38 (FIG. 5) froman alignment pin assembly 21 to capture tissue between anvil assembly 22and cartridge assembly 20. A release button 150 of a release mechanism(not shown) is positioned on the proximal end of body 12 and isdepressible to allow cartridge assembly 20 to return from anapproximated position disposed adjacent to anvil assembly 22 to anunapproximated position spaced from anvil assembly 22 (as shown).

With continued reference to FIG. 1, body 12 is formed from a pair ofmolded half-sections 12 a, 12 b. In one embodiment, half-sections 12 a,12 b are formed of plastic, although half-sections 12 a, 12 b may beformed of other materials, including metal. Body 12 further includes aplurality of LED indicators 13 a-c. It should be understood that not allthe indicators need to be provided, and in some embodiments there arefewer than the three shown. As shown, a pin alignment LED indicator 13 ais positioned on half-section 12 b of body 12 while clamping andstapling LED indicators 13 b, 13 c are located on release member 150. Itis envisioned, however, that LED indicators 13 a-c may be positioned onother locations on body 12. As will be discussed in further detailbelow, pin alignment LED indicator 13 a is configured to illuminate whenalignment pin 38 operably engages an end cap 39 on anvil assembly 22,clamping LED indicator 13 b is configured to illuminate when surgicalstapler 10 has completed an approximation stroke, and stapling LEDindicator 13 c is configured to illuminate when surgical stapler 10 hascompleted the stapling (firing) stroke. LED indicators 13 a-c may becolor coded, or instead, may correspond to markings near respective LEDindicators 13 a-c.

With reference to FIG. 4, by way of example, clamping LED indicator 13 bis located proximate clamp symbol “C” and stapling LED indicator 13 c islocated proximate staple symbol “S”. Symbols “C”, “S” may be icons orpictures, as shown, or may instead include one or more numbers, one ormore letters, one or more colors, or any combination thereof or anyother indicia. Although shown and described as being LEDs, indicators 13may instead include a conventional bulb or other suitable light emittingsource.

The structure and function of surgical stapler 10 will now be describedto the extent necessary to fully disclose the aspects of the presentdisclosure. A more detailed discussion of the structure and function ofthe surgical stapler is disclosed in U.S. Pat. No. 6,817,508 (the '508patent), the entire contents of which are incorporated by referenceherein. Also, the term surgical stapling as used herein includesapplication of two part fasteners.

Referring now to FIG. 2, surgical stapler 10 includes a pair of clampslide members 66 (only one shown) and a thrust bar 70. Clamp slidemembers 66 and thrust bar 70 are slidably supported between a pair offrame members 28 (only one shown—28 a) of surgical stapler 10 formovement between retracted and advanced positions in response tomovement of trigger 16 through an approximation stroke and a staplingstroke. Clamp side members 66 and thrust bar 70 advance distallytogether during the approximation stroke and thrust bar 70 advancesfurther distally during the staple firing stroke. Cartridge assembly 20is operably connected at a distal portion (not shown) of clamp slidemembers 66 such that advancement of clamp slide members 66 effectsadvancement of cartridge assembly 20. Cartridge assembly 20 is operablyconnected at a distal portion (not shown) of thrust bar 70 such thatadvancement during the firing stroke effects ejection of staples fromcartridge assembly 20 into contact with anvil pockets on anvil assembly22. Thrust bar 70 includes a flange 70 a formed in a proximal endthereof.

Still referring to FIG. 2, maintained within body 12 of surgical stapler10 is a clamping indicator mechanism 73 and a stapling indicatormechanism 83. Each of indicator mechanisms 73, 83 include an actuator75, 85, respectively, and a switch assembly 77, 87, respectively.Clamping indicator mechanism 73 is electrically connected to clampingLED indicator 13 b located on release button 150, by wires (not shown)for example, and is configured to provide visual indication to a userwhen surgical stapler 10 has completed the approximation stroke.Stapling indicator mechanism 83 is electrically connected to staplingLED indicator 13 c, by wires (not shown) for example, and is configuredto visually indicate to a user when surgical stapler 10 has completedthe stapling stroke, i.e. when the staples have been fired. As shown, abattery 55 is electrically connected to each of clamping indicatormechanism 73 and stapling indicator mechanism 83; however,alternatively, each of indicator mechanisms 73, 83 may be electricallyconnected to individual batteries (not shown).

Still referring to FIG. 2, clamping actuator 75 is mounted to clampslide member 66 in any suitable manner e.g. clamped, screwed, etc.Alternatively, clamping actuator 75 may be integrally formed with clampslide member 66. Clamping switch assembly 77 is mounted on an innersurface of half-section 12 a in a position to be engaged by clampingactuator 75 upon complete distal advancement of clamp slide members 66.Complete distal advancement of clamp slide member 66 occurs at thecompletion of the cartridge approximation stroke which brings thecartridge assembly into approximation with the anvil assembly. Clampingswitch assembly 77 includes any switching mechanism capable ofcompleting a circuit upon engagement of actuator 75. In one embodiment,clamping switch assembly 77 includes a lever or switch (not shown) thatdeflects upon engagement with switch actuator 75. In an alternativeembodiment, clamping actuator 75 includes a conductive portion (notshown) that completes a circuit upon engagement with clamping switchassembly 77.

With continued reference to FIG. 2, stapling actuator 85 is mounted toflange 70 a of thrust bar 70 in any suitable manner. Alternatively,stapling actuator 85 can be integrally formed with thrust bar 70.Stapling switch assembly 87 is mounted on an inner surface ofhalf-section 12 a in a position to be engaged by stapling actuator 85upon complete distal advancement of thrust bar 70. Complete distaladvancement of thrust bar 70 occurs at the completion of the staplefiring stroke to advance the staples from cartridge assembly 20 intocontact with anvil pocket. Stapling switch assembly 87 includes anyswitching mechanism capable of completing a circuit upon engagement withstapling actuator 85. In one embodiment, stapling switch assembly 87 mayinclude a lever or switch (not shown) that deflects upon engagement withstapling actuator 87. In an alternative embodiment, stapling actuator 85includes a conductive portion (not shown) that completes a circuit uponengagement of stapling switch assembly 87.

Although, as shown, each of clamping and stapling indicator mechanisms73, 83 includes only a single actuator 75, 85, respectively, and singleswitch assembly 77, 87, respectively, each of clamping and staplingindicator mechanisms 73, 83 may include a second switch assembly (notshown) mounted within half section 12 b. The second switch assembly ofclamping indicator mechanism 73 would correspond to a second actuator(not shown) mounted on the second slide clamp member (not shown) andwould operate in a manner similar to actuator 73 and switch assembly 75to cause the illumination of clamping LED indicator 13 b upon completedistal advancement of the second slide clamp member. Stapling actuator85 may be modified to engage the second switch assembly of the staplingmechanism 83, or instead a second stapling actuator (not shown) may beadded to thrust bar 70 to engage the second switch assembly.

Referring now to FIGS. 5 and 6, surgical stapler 10 also includes a pinalignment indicator mechanism 93 operably mounted within alignment cap39 of anvil assembly 22. Alignment cap 39 includes a pin receivingopening 39 a configured for selectively receiving alignment pin 38. Thealignment opening 39 a can be angled to provide a lead in for thealignment pin 38. Pin alignment mechanism 93 includes a pin alignmentswitch assembly 97 (shown in phantom). Switch assembly 97 is configuredto illuminate pin alignment LED indicator 13 a (FIG. 1) formed onhalf-section 12 a upon reception of alignment pin 38 within opening 39 aof alignment cap 39. Reception of alignment pin 38 within opening 39 aof alignment cap 39 occurs prior to the approximation stroke to capturetissue (not shown) between cartridge assembly 20 and anvil assembly 22.Pin alignment switch assembly 97 includes any switching mechanismcapable of completing a circuit upon reception of alignment pin 38within opening 39 a of alignment cap 39. In one embodiment, alignmentswitch assembly 97 includes a lever or switch (not shown) that deflectsupon engagement with alignment pin 38. In an alternative embodiment,alignment pin 38 may include a conductive portion (not shown) thatdefines a portion of an electrical circuit upon engagement with pinalignment switch assembly 97. As discussed above, alignment pin 38 maybe manually advanced using thumb buttons 24, or automatically advancedduring the approximation stroke of stapler 10, as described in detail inthe '508 patent incorporated by reference above. Pin alignment switchassembly 97 is electrically connected to battery 55 (FIG. 2) and pinalignment LED indicator 13 a by wires “W”. Wires “W” may be disposed onan outer portion of body 12, as shown, or preferably may instead bemaintained within half-sections 12 a, 12 b of body 12.

With reference now to FIGS. 7-11, the operation of surgical stapler 10and indicator assemblies 73, 83, 93 will be described. With referenceinitially to FIG. 7, surgical stapler 10 is shown in a first orpre-clamped condition. Alignment pin 38 has been manually advanced usingthumb buttons 24. Engagement of alignment pin 38 with pin alignmentswitch assembly 97 (FIG. 5) upon receipt of alignment pin 38 throughopening 39 a of alignment cap 39 causes illumination of pin alignmentLED indicator 13 a. Illumination of pin alignment LED indicator 13 aprovides visual indication to the user that alignment pin 38 has beenreceived within opening 39 a of alignment cap 39.

Turning now to FIGS. 8 and 9, trigger 16 is moved towards stationaryhandle 14, in the direction indicated by arrow “A”, to advance clampslides 66 (FIG. 2) from a retracted position towards the advanced orapproximated position. As discussed above, upon complete advancement ofclamp slide member 66, clamping actuator 75 engages clamping indicatorswitch assembly 77 to cause the illumination of clamping LED indicator13 b. Illumination of clamping LED indicator 13 b provides visualindication to the user that the clamping stroke is complete and thatsurgical stapler 10 is in a clamped condition. If, during theapproximation stroke surgical stapler 10, clamping actuator 75 does notengage clamping indicator switch assembly 77, clamping LED indicator 13b would not be illuminated. Note that indicator 13 a preferably remainsilluminated.

As discussed in detail in the '508 patent, after the approximationstroke of trigger 16 is completed, trigger 16 returns to anon-compressed position upon its release to ready surgical stapler 10for the staple firing (stapling) stroke. Prior to the stapling stroke,tissue (not shown) is captured between cartridge assembly 20 and anvilassembly 22 by the alignment pin 38 (FIG. 4).

FIGS. 10 and 11 illustrate surgical stapler 10 after trigger 16 has beenmoved through the stapling stroke, as indicated by arrow “B”. During thestapling stroke, thrust bar 70 moves independently of clamp slidemembers distally within body 12. As discussed above, complete distaladvancement of thrust bar 70 causes engagement of stapling actuator 85with stapling indicator switch assembly 87 to cause the illumination ofstapling LED indicator 13 c. Illumination of stapling LED indicator 13 cvisually indicates to a user that surgical stapler 10 has successfullycompleted the staple firing stroke. Note indicators 13 a and 13 bpreferably remain illuminated. If, during the stapling stroke staplingLED indicator 13 c fails to illuminate, the user is provided with visualindication that surgical staples have not been fired.

With continued reference to FIG. 10, upon completion of the staplingstroke, release button 150 is depressed and a spring (not shown) returnsthrust bar 70 (FIG. 2) and clamp slide members 66 (FIG. 2) proximally tothe initial or pre-clamped position, and the indicators are no longerilluminated. Surgical stapler 10 is then ready for reloading and use.

It will be understood that various modifications may be made to theembodiments disclosed herein. For example, the components of thesurgical stapling device can be formed of any material suitable forsurgical use and having the required strength characteristics.Therefore, the above description should not be construed as limiting,but merely as exemplifications of preferred embodiments. Those skilledin the art will envision other modifications within the scope and spiritof the claims appended hereto.

1. A surgical stapler comprising: a body; a stapling assembly positionedat a distal portion of the body, the stapling assembly including acartridge assembly and an anvil assembly; an alignment pin mounted onthe stapling assembly and configured to engage the anvil assembly; and apin receiving mechanism positioned on the anvil assembly and configuredto illuminate a first visual indicator upon engagement of the alignmentpin with the anvil assembly.
 2. The stapler of claim 1 wherein the pinreceiving mechanism is an alignment mechanism and includes an alignmentcap mounted on an end of the anvil assembly and an opening therein forreceiving the alignment pin, and a switch assembly mounted within thealignment cap configured to effect illumination of the first visualindicator upon reception of the alignment pin in the opening in thealignment cap.
 3. The stapler of claim 1, wherein the first visualindicator includes an LED mounted on the body.
 4. The stapler of claim1, further comprising: a clamp slide member slidably disposed within thebody, the cartridge assembly supported adjacent a distal portion of theclamp slide member, the clamp slide member being movable from aretracted position to an advanced position to approximate the cartridgeassembly towards the anvil assembly; and a clamping indicator mechanismconfigured to illuminate a second visual indicator upon approximation ofthe cartridge assembly.
 5. The stapler of claim 4, wherein the clampingindicator mechanism is operably mounted between the body and the clampslide member.
 6. The stapler of claim 5, wherein the clamping indicatormechanism includes an actuator mounted to the clamp slide member and aswitch assembly mounted to the body and configured to be engaged by theactuator and the actuator is configured to engage the switch assemblyupon complete distal advancement of the clamp slide member.
 7. Thestapler of claim 4, wherein the second visual indicator includes an LEDmounted on the body.
 8. The stapler of claim 1, further comprising: athrust bar slidably disposed within the body and operably connected tothe cartridge assembly to cause the release of staples therefrom upondistal advancement of the thrust bar; and a stapling indicator mechanismbeing configured to illuminate a stapling visual indicator upon releaseof the staples from the cartridge assembly.
 9. The stapler of claim 8,wherein the stapling indicator mechanism is operably mounted between thebody and the thrust bar.
 10. The stapler of claim 8, wherein thestapling indicator mechanism includes an actuator mounted to the thrustbar and a switch assembly mounted to the body and configured to beengaged by the actuator.
 11. The stapler of claim 10, wherein theactuator is configured to engage the switch assembly upon completedistal advancement of the thrust bar.
 12. The stapler of claim 11,wherein the stapling visual indicator includes an LED mounted on thebody.
 13. The stapler of claim 4, further comprising: a thrust barslidably disposed within the body and operably connected to thecartridge assembly to cause the release of staples therefrom upon distaladvancement of the thrust bar; and a stapling indicator mechanism beingconfigured to illuminate a stapling visual indicator upon release of thestaples from the cartridge assembly.
 14. A surgical stapler comprising:a body; a stapling assembly positioned at a distal portion of the body,the stapling assembly including a cartridge assembly and an anvilassembly; a clamp slide member slidably disposed within the body, thecartridge assembly supported adjacent a distal portion of the clampslide member, the clamp slide member being movable from a retractedposition to an advanced positioned to approximate the cartridge assemblytowards the anvil assembly; and a clamping indicator mechanism operablymounted between the body and the clamp slide member, the clampingmechanism being configured to illuminate a visual indicator uponcomplete advancement of the clamp slide member.
 15. The stapler of claim14, wherein the clamping indicator mechanism includes an actuatormounted to the clamp slide member and a switch assembly mounted to thebody and configured to be engaged by the actuator.
 16. The stapler ofclaim 15, wherein the actuator is configured to engage the switchassembly upon complete distal advancement of the clamp slide member. 17.The stapler of claim 14, further comprising: a thrust bar slidablydisposed within the body and operably connected to the cartridgeassembly to cause the release of staples therefrom upon distaladvancement of the thrust bar; a stapling indicator mechanism beingconfigured to illuminate a stapling visual indicator upon release of thestaples from the cartridge assembly; wherein the stapling indicatormechanism is operably mounted between the body and the thrust bar.
 18. Astapler comprising: a body; a stapling assembly positioned at a distalportion of the body, the stapling assembly including a cartridgeassembly and an anvil assembly; a thrust bar slidably disposed withinthe body and operably connected to the cartridge assembly to cause therelease of staples therefrom upon complete distal advancement of thethrust bar; and a stapling indicator mechanism operably mounted betweenthe body and the thrust bar, the stapling indicator mechanism beingconfigured to illuminate a stapling visual indicator upon release ofstaples from the cartridge assembly.
 19. The stapler of claim 18,wherein the stapling visual indicator includes an LED mounted on thebody.
 20. The stapler of claim 18, wherein the stapling indicatormechanism includes an actuator mounted to the thrust bar and a switchassembly mounted to the body and configured to be engaged by theactuator, and wherein the actuator is configured to engage the switchassembly upon complete distal advancement of the thrust bar.